Oct 5, 2016
EMERGO SUMMARY OF KEY POINTS:
Medical device market regulators in Colombia have begun allowing speedier renewals for licenses of lower-risk products.
As of October 3, 2016, Colombia’s medical device market regulator INVIMA implemented a new policy (link in Spanish) whereby registrants that submit applications for renewals to the institute will be granted such requests within three days of receipt rather than within one to two months, as is currently the case for registration renewals. The new policy pertains to Class I and IIa devices.
For additional information on Colombia’s medical device registration and renewal process, download our regulatory chart or watch our video overview.
INVIMA, Colombia's medical device market regulator, has published an updated list of products that qualify as medical devices, expanding the pool of medical products that require market authorization to be legally sold in the country.
INVIMA, the Colombian medical device market regulator, has announced that medical displays are now considered Class IIa medical devices subject to registration requirements in the country.